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Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples

Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06651346
Enrollment
100
Registered
2024-10-21
Start date
2025-02-01
Completion date
2027-01-01
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Keywords

ERCP, Cytology

Brief summary

Cholangiocarcinoma is a malignancy that is most-often diagnosed with ERCP-directed cytology brushings of the biliary tree, but the yield on this cytology has been previously shown to only be 5%-40%. Additionally, the vast majority (approximately 80%) of patients are not diagnosed until they are surgically unresectable (due to late stage at time of diagnosis), at which point there is no chance for cure and their only options are palliative. Therefore, better diagnostic modalities are needed. Plectin is a structural protein located inside of most cells, but it has been shown to be expressed on the cell surface of malignant cells in the pancreaticobiliary tract. The investigators hypothesize that ERCP-guided biliary samples can provide cells and immunohistochemical staining can detect cell surface plectin in patients with cholangiocarcinoma. This would be a novel diagnostic tool which could greatly reduce the time to diagnosis. A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible. In this current study, patients with a biliary stricture or tumor who are already undergoing ERCP as part of their routine clinical care (i.e. no procedures will be done exclusively for this research study) will undergo an additional biopsy and/or brushing to be assessed for cell-surface plectin expression via immunohistochemistry. The investigators hypothesize that plectin immunohistochemistry will have a higher sensitivity for cholangiocarcinoma than biopsies and/or brushings (cytology) alone.

Interventions

None listed

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Biliary stricture or mass seen on imaging; already undergoing ERCP as part of their routine clinical care

Exclusion criteria

* Age \< 18 years old; inability to consent

Design outcomes

Primary

MeasureTime frameDescription
Positive plectin staining on IHC from ERCP-directed biliary samples2 yearsPositive plectin staining on IHC from ERCP-directed biliary samples

Countries

United States

Contacts

Primary ContactRoss Buerlein, Medical Doctor
rcb9n@uvahealth.org434-982-2481

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026